Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers

NCT01222962 | Completed Phase 1

• 1 other identifier: ST3073/ST3074-DM09-008
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed to assess the effect of food on the extent and rate of absorption of Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose combination (Eurartesim™).

Conditions

Malaria, Falciparum

Outcome Measures

Primary Outcomes (1)

• tmax, Cmax, AUC0-last, AUC0-24 [PQ], and AUC0-inf, λz, t1/2, Cl/F, Vz/F [DHA].

  Blood samples for determination of plasma DHA were collected at the following times: At pre-dose Day 0 and then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. Blood samples for determination of plasma PQ were collected at the following times: At pre-dose Day 0 and then at 1, 2, 3, 4, 5, 6, 8, and 12 hours post-dose; on Day 1, 2, 3, 4, 5 and 7.

  from the day of study drug administration, till Day 7 follow-up

Secondary Outcomes (3)

• Number of Treatment Emergent Adverse Events

  Day 0 and till Day 30 follow-up

• Hematology and blood chemistry changes respect to baseline values

  Day 0, day 2, day 30

• QTc interval prolongation

  Day 0, day 2, day 30

Study Arms (2)

fed treatment

EXPERIMENTAL

18 healthy volunteers administered with a single dose of Eurartesim

Drug: Eurartesim

Fasted Treatment

EXPERIMENTAL

18 healthy volunteers treated with a single dose of Eurartesim

Drug: Eurartesim

Interventions

Eurartesim DRUG

Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.

Fasted Treatment; fed treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian healthy males aged between 18 and 50 years(inclusive).
• Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 75 kg.
• Agreed to use two approved methods of contraception from Screening and until 90 days after administration of the study drug
• Had given written informed consent to participate in this study in accordance with local regulations.

You may not qualify if:

• Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing or an over-the-counter medicine 48 hours prior to the start of dosing.
• Abnormal laboratory test results deemed clinically significant by the Medical Officer.
• Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.
• History of significant drug allergies or significant allergic reaction.
• Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration.

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead
• CPR Pharma Services Pty Ltd, Australia: collaborator

Study Sites (1)

CMAX, a division of IDT Australia Limited

Adelaide, SA 5000, Australia

Location

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 18, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 18, 2010

Record last verified: 2010-10

Locations

AU (1)